(22 days)
No
The device description focuses on physical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies described are also related to physical properties like stiffness and insertion force.
No.
The device is a guiding sheath and exchange dilator system used to facilitate the introduction, stability, and exchange of electrophysiology catheters for ablation procedures, but it does not directly perform the therapeutic ablation itself.
No
The device description and intended use clearly state that this device is a guiding sheath system used for the introduction of electrophysiology catheters and for providing stability and directional control during transcatheter ablation. Its primary function is to facilitate a therapeutic procedure (ablation) by guiding other instruments, not to diagnose a condition or disease.
No
The device description explicitly details physical components such as guiding sheaths, dilators, guidewires, and funnels, and discusses modifications to these physical components (e.g., adding radiopaque tips). There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide stability and directional control during transcatheter ablation of endocardial tissue and for the introduction and exchange of intravascular electrophysiology catheters into cardiac chambers. This is a procedural device used in vivo (within the body) for a therapeutic and diagnostic procedure (ablation and electrophysiology).
- Device Description: The components are guiding sheaths, dilators, and guidewires. These are all instruments used to access and navigate within the cardiovascular system.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of this device and its intended use do not involve the analysis of biological specimens.
Therefore, this device falls under the category of an invasive medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The PREFACE Braided Guiding Sheath is intended for the introduction of intravascular electrophysiology catheters into any cardiac chamber.
The intended use of the PERRY Exchange Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular electrophysiology catheters. The exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.
Product codes (comma separated list FDA assigned to the subject device)
74 DYB
Device Description
The components of the Predicate Device (K970264) consists of 1) a Guiding Sheath with posterior, anterior or multipurpose shaped distal tip section, 2) a conventional sheath vessel dilator (vessel dilator), 3) a dual-tapered long vessel dilator (exchange dilator), 4) a .032", 260cm guidewire, and 5) a guidewire funnel. The components of the Predicate Device are packaged in four configurations: 1) Guiding Sheath w/ posterior curve and vessel dilator, 2) Guiding Sheath w/ anterior curve and vessel dilator, 3) Guiding Sheath w/ multipurpose curve, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel, and 4) Posterior, Anterior and Multipurpose Guiding Sheaths, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel.
The packaging configuration of the Predicate Device has been modified to offer the Guiding Sheath and Exchange System in two separate packages. The Guiding Sheath (PREFACE Braided Guiding Sheath) with posterior, anterior or multipurpose shaped distal tip sections is packaged with a vessel dilator and a short .032", 150cm guidewire. The Exchange System includes the exchange dilator (PERRY Exchange Dilator), .032", 260cm guidewire, and guidewire funnel. The distal end of the vessel dilator and both ends of the PERRY Exchange Dilator were modified by adding radiopaque tips with tungsten to improve visibility under fluoroscopy. The function and intended use of the Modified Device as compared to the Predicate Device are identical, as are all component materials with the exception of the tungsten dilator material. The addition of the tungsten material does not affect safety or effectiveness as demonstrated in the Verification Test Data provided in Appendix I.
The PREFACE Braided Guiding Sheaths are intended to provide stability and directional control during catheter ablation. The PREFACE Braided Guiding Sheath is packaged with a vessel dilator with a radiopaque distal tip, and a .032", 150cm guidewire. The PERRY Exchange Dilator will be utilized by the physician to exchange the existing PREFACE Braided Guiding Sheath for an alternate PREFACE Braided Guiding Sheath without losing the established intracardiac position. The PERRY Exchange Dilator with radiopaque ends is packaged with a .032", 260cm guidewire and guidewire funnel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac chamber
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing of the Modified Device was conducted to compare the stiffness and the insertion force of the PERRY Exchange Dilator with radiopaque tip and the dilator (of the PREFACE Braided Guiding Sheath) with the standard 8F AVANTI Sheath (K970392).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
AUG 28 1998
Special 510(k): Device Modificatio Cordis Webster Braided Guiding Sheath Exchange System
Appendix A: 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under the
Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is
summarized below. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | For the convenience of the Reviewer, this summary is formatted in
accordance with the Agency's final rule "...510(k) Summaries and 510(k)
Statements..." (21 CFR §807) and can be used to provide a substantial
equivalence summary to anyone requesting it from the Agency. |
| Device
description | The components of the Predicate Device (K970264) consists of 1) a Guiding
Sheath with posterior, anterior or multipurpose shaped distal tip section, 2) a
conventional sheath vessel dilator ( vessel dilator ), 3) a dual-tapered long
vessel dilator ( exchange dilator ), 4) a .032", 260cm guidewire, and 5) a
guidewire funnel. The components of the Predicate Device are packaged in
four configurations: 1) Guiding Sheath w/ posterior curve and vessel dilator,
2) Guiding Sheath w/ anterior curve and vessel dilator, 3) Guiding Sheath w/
multipurpose curve, vessel dilator, exchange dilator, .032", 260cm guidewire
and guidewire funnel, and 4) Posterior, Anterior and Multipurpose Guiding
Sheaths, vessel dilator, exchange dilator, .032", 260cm guidewire and
guidewire funnel. |
| | The packaging configuration of the Predicate Device has been modified to
offer the Guiding Sheath and Exchange System in two separate packages.
The Guiding Sheath ( PREFACE Braided Guiding Sheath ) with posterior,
anterior or multipurpose shaped distal tip sections is packaged with a vessel
dilator and a short .032", 150cm guidewire. The Exchange System includes
the exchange dilator ( PERRY Exchange Dilator ), .032", 260cm guidewire,
and guidewire funnel. The distal end of the vessel dilator and both ends of the
PERRY Exchange Dilator were modified by adding radiopaque tips with
tungsten to improve visibility under fluoroscopy. The function and intended
use of the Modified Device as compared to the Predicate Device are identical,
as are all component materials with the exception of the tungsten dilator
material. The addition of the tungsten material does not affect safety or
effectiveness as demonstrated in the Verification Test Data provided in
Appendix I. |
| Device
Description -
Continued | The PREFACE Braided Guiding Sheaths are intended to provide stability and
directional control during catheter ablation. The PREFACE Braided Guiding
Sheath is packaged with a vessel dilator with a radiopaque distal tip, and a
.032", 150cm guidewire. The PERRY Exchange Dilator will be utilized by
the physician to exchange the existing PREFACE Braided Guiding Sheath for
an alternate PREFACE Braided Guiding Sheath without losing the established
intracardiac position. The PERRY Exchange Dilator with radiopaque ends is
packaged with a .032", 260cm guidewire and guidewire funnel. |
| Intended use | The intended use of the Modified Device is to provide stability and directional
control during transcatheter ablation of endocardial tissue. |
| Indications
statement | PREFACE Braided Guiding Sheath - The intended use of the percutaneous
Braided Guiding Sheath is for the introduction of intravascular
electrophysiology catheters into any cardiac chamber.
|
| | PERRY Exchange Dilator - The intended use of the PERRY Exchange
Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular
electrophysiology catheters. The exchange dilator permits exchange of the
guiding sheaths while maintaining transseptal left heart access and control of
sheath location. |
| Technological
characteristics | The technological characteristics of the Modified Device are the same as the
Predicate Device. |
| | Continued on next page |
| Performance
data | Verification testing of the Modified Device was conducted to compare the
stiffness and the insertion force of the PERRY Exchange Dilator with
radiopaque tip and the dilator (of the PREFACE Braided Guiding Sheath)
with the standard 8F AVANTI Sheath (K970392). |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) and
the information provided herein, we conclude that the Modified Device is
substantially equivalent to the Predicate Device under the Federal Food, Drug
and Cosmetic Act. |
| Contact | Mary Adams
Regulatory Affairs Manager
Cordis Webster, Inc.
4750 Littlejohn Street
Baldwin Park, CA 91706 |
| Date | August 5, 1998 |
Continued on next page
1
Appendix A: 510(k) Summary of Safety and Effectiveness, Continued
2
Appendix A: 510(k) Summary of Safety and Effectiveness,
Continued
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 28 1998
Ms. Mary Adams Requlatory Affairs Manager Cordis Webster, Inc. 4750 Littlejohn Street Baldwin Park, CA 91706
Re: K982740 Cordis Webster PREFACE Braided Guiding Sheath and PERRY Exchange Dilator Regulatory Class: II (two) Product Code: 74 DYB Dated: Auqust 5, 1998 Received: Auqust 6, 1998
Dear Ms. Adams:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturinq Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
4
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, ² Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix B: Indications for Use Statement
Statement
Indications for Use Statement:
510(k) Number: K_982740
Device Name: PREFACE Braided Guiding Sheath and PERRY Exchange Dilator
Indications for Use: The PREFACE Braided Guiding Sheath is intended for the introduction of intravascular electrophysiology catheters into any cardiac chamber.
Indications for Use: The intended use of the PERRY Exchange Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular electrophysiology catheters. The exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.
Qarly Tillh
Prescription Use
(Per 21 CFR 801.109)